MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ULTRAVAC; APPARATUS, EXHAUST, SURGICAL

Model Number 2110-10EC

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2020

Event Type  malfunction  

Event Description

After incision was made, bovie was attempted to use and did not activate on field.No fault alarms alerted.Grounding pad was checked and was in the green.Hand piece and grounding pad were disconnected and reconnected.No error messages, but still would not activate.A new hand piece was opened, no change.A new bovie pad was placed on the patient; no change.A new machine was brought in the room and bio med was called.Hand piece still did not work.Bio med checked the machine with a test hand piece which did work correctly.Bio-med suggested a new hand piece from a different lot number.A new lot number was opened and worked without issue on both machines (covidien valley lab consoles cn50920/cn50754).Bovie site was clear of an injury.No harm to patient was evident but did cause a delay intra-operatively.

• Brand Name: ULTRAVAC
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s. state st; draper UT 84020
• MDR Report Key: 10100787
• MDR Text Key: 192679917
• Report Number: 10100787
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104743
• UDI-Public: (01)10614559104743
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2110-10EC
• Device Lot Number: 7913
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1